Device product
NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
Z-0309-2022
Product summary
- Event
- Event 88941
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0309-2022
Official wording
Reason: Endotoxin levels exceeded allowable limits.
Code information: Lot Code: 20C015 UDI: 00850392006544
Distribution pattern: US in the state of MO
Derived failure modes
-
Unknown
Endotoxin levels exceeded allowable limits.